NL-OMON52558招募中2 期
Synaptic density and tau pathology in Alzheimer's disease - SYNAPSE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- At least 50 years of age;
- •- Biomarker evidence (CSF or PET) for the presence of Aβ pathology.
- •- Subjects must, in the opinion of the principal investigator/attending
- •neurologist, be able to tolerate study procedures and be competent to make a
- •well-informed decision to participate in this study;
- •- Signed informed consent for Amsterdam Dementia Cohort 2016.061);
排除标准
- •- Has contra indications for MRI scanning and therefore has and cannot receive
- •- Has evidence of structural abnormalities such as major stroke or mass on MRI
- •that is likely to interfere with the clinical presentation and/or
- •interpretation of PET scan;
- •- Is a woman of childbearing potential who is not surgically sterile, not
- •refraining from sexual activity or not using reliable methods for
- •contraception. Women of childbearing potential must orally confirm not to be
- •pregnant or breast feeding at screening;
- •- Has a relevant history of severe drug allergy or hypersensitivity. Relevant
- •severe drug allergies should be determined by the Principal Investigator;
- •- Has ever participated in an experimental study with a tau, amyloid or synapse
- •targeting agent, unless it can be documented that the subject received only
- •placebo during the course of the trial;
- •- Has been injected with a previously administered radiopharmaceutical within 6
- •terminal half-lives or when total yearly radiation exposure exceeds 11.3 mSv
- •for females and 15.3 mSv for males;
- •- History of any clinically significant cardiovascular, endocrinology,
- •hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary,
- •neurologic (with the exception of AD), psychiatric, renal or other major
- •disease, as determined by the principal investigator;
- •- Is a member of the study team, an employee of the department of Radiology
- •and Nuclear medicine or the department of Neurology of the Amsterdam UMC, or is
- •related to an employee of department of Radiology and Nuclear medicine or the
- •department of Neurology of the Amsterdam UMC.
- •- The following medications during the study and 4 weeks prior to [11C]UCB-J
- •o Use of anticonvulsant medications;
- •o Other medications that, in the opinion of the Investigator, may interfere
- •with the study.
研究者
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